The growing number of ethics committees (ECs) indicates that significant changes have occurred in the decision making process in the clinical setting in Japan. The purposes of this study are to : 1) investigate the current status ; 2) make guidelines for establishing and running an EC in a general hospital setting ; 3) to explore the degree of discretion and responsibility of the EC, and 4) to make a comprehensive proposal. To achieve the above goals, several surveys were conducted.1) General hospitals (1996). A self-administered questionnaire was sent to directors of 3,098 general hospitals (recovery rate: 44%). About 15% had ECs. The problems they faced were unclearness of their responsibilities , financial issues , and no uniform decision making criteria.2) Medical schools (1995-1996). A self-administered questionnaire was sent to the EC of all 80 medical schools, asking about the current status (recovery rate: 100%). More than half of them answered that they would review issues independently from academic societies and ministries.3) Academic societies (1998). A self-administered questionnaire was sent to directors of 137 societies (recovery rate: 88%). Twenty-eight societies had ECs. Most societies answered that they would not intervene but just make objections when their opinions conflicted with medical schools' decisions.4) The Ministry of Health and Welfare (1999). Semi-structured interviews were performed with two officers who were engaged in policy making. The Ministry basically regulates and intervenes in the issues that are legalized such as organ transplantation. Other issues are handled case by case.Finally, for the question "Is the Japanese EC system unique?", we would answer that factors such as member constitution, location, and topics discussed seem to be similar to ones in other countries . Rather than the outlook, the difference might exist in its decision making procedures such as a consensus-seeking tendency, and needs further analysis.